Original Investigation
Frontalis Suspension With Supramid Suture: Longevity Results in Very Young Patients With Congenital Ptosis Rebecca E. Tanenbaum, Wei Shi, M.S., Thomas E. Johnson, M.D., and Sara T. Wester, M.D. Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida
Purpose: To evaluate the duration of effect of frontalis suspension using Supramid suture (polyfilament, cable-type 3-0 suture) technique in very young children with congenital ptosis. Methods: The authors performed a retrospective review of 44 patients aged 4 years or less who underwent frontalis suspension using Supramid at the Bascom Palmer Eye Institute. Surgical success was defined as good eyelid height and position. Duration of the sling was defined as the time from initial surgery until additional surgery was performed or the date of last follow up. Kaplan-Meier survival analysis was performed with failure time measured as time from initial surgery until additional surgery was performed. Results: Kaplan-Meier survival analysis showed a success rate of 87.5% at 1 year, 78.2% at 2 years, 74.5% at 3 years, 58.2% at 4 years, and 53.7% at 5 years. Complications were noted in 10 cases (23%) and included damage to the Supramid sling secondary to trauma and granuloma formation. Conclusions: Given the ready availability, ease of placement, and reliable cosmetic and functional results, Supramid suture is an excellent temporizing treatment option in cases of early amblyogenic congenital ptosis in children 2 mm) were demonstrated in 5 of these cases. In these 5 cases, reoperation was not recommended, and the mean increase in PF at last follow up was 3 mm (SD = 2). Those eyes that did require reoperation had a mean PF increase of 1 mm postoperatively. While this 2 mm difference in postoperative PF values was not statistically significant (p = 0.086), the 95% confidence interval (−5 to 0.4 mm) also supports the correlation between quantitative data and need for reoperation. A Kaplan-Meier survival analysis was also performed to analyze the relationship between surgical technique and success of surgery (see Table 2 and Fig. 2). The cumulative probability of Supramid sling failure was 12.4% at 1 year, 24.3% at 2 years, 24.3% at 3 years, 44.7% at 4 years, and 50.2% at 5 years in double rhomboid group and 12.5% at 1 year, 12.5% at 2 years, 30.0% at 3 years, 30.0% at 4 years, and 30.0% at 5 years in pentagonal group (p = 0.96, log rank test). No statistically different failure rate was observed between the 2 surgical methods. Of the total 44 cases reviewed, 5 cases (11%) developed granulomas, all of which were treated with eventual surgical removal of the Supramid suture and 3e of which underwent sling replacement. In these cases, the average time to repeat surgical intervention was 17 months (range 5 months to 3 years), and 4 of the 5 required sling removal at the time of granuloma excision. Three of these cases later had sling replacement with one of each of the following materials: autologous fascia lata, Supramid, and silicone. There
TABLE 1. Kaplan-Meier survival analysis
Time (mo) 3 6 12 24 36 48 60
Cumulative proportion survival at the time
Cumulative proportion failure at the time (1–survival)
SE
0.952 0.904 0.875 0.782 0.745 0.582 0.537
0.048 0.096 0.125 0.218 0.255 0.418 0.463
0.033 0.046 0.052 0.069 0.075 0.093 0.096
Survival is defined as no reoperation to remove or replace sling
© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
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Ophthal Plast Reconstr Surg, Vol. 30, No. 2, 2014
R. E. Tanenbaum et al.
FIG. 1. Kaplan-Meier plot of the probability of Supramid sling failure defined as reoperation to remove or replace. were no cases of significant corneal exposure problems. Infection was noted in 1 case. Trauma was documented in 5 cases (11%); however, in 2 cases, surgical repair was not initially performed. In those cases, trauma had little to no effect on the eyelid position, but additional surgery was eventually required due to gradual worsening of the ptosis over the following years. In the other 3 cases, there was a clear temporal relationship between the trauma and breakage of the Supramid, and immediate replacement of the Supramid sling was performed. Thirteen cases (30%) were noted to have preexisting amblyopia in the ptotic eye. Two patients without preexisting amblyopia developed worsening vision postoperatively. One case developed amblyopia 1 year after sling placement, which resolved after placement of a fascia lata sling, and vision has been stable since. Another case of
DISCUSSION
TABLE 2. Kaplan-Meier survival analysis Cumulative proportion survival at the time (SE) Time (mo) 3 6 12 24 36 48 60 3 6 12 24 36 48 60
Double rhomboid
Pentagonal
p*
0.941 (0.04) 0.911 (0.05) 0.876 (0.06) 0.757 (0.08) 0.757 (0.08) 0.553 (0.11) 0.498 (0.11) 0.059 (0.04) 0.089 (0.05) 0.124 (0.06) 0.243 (0.08) 0.243 (0.08) 0.447 (0.11) 0.502 (0.11)
1.0 0.875 (0.12) 0.875 (0.12) 0.875 (0.12) 0.700 (0.18) 0.700 (0.18) 0.700 (0.18) 0 0.125 (0.12) 0.125 (0.12) 0.125 (0.12) 0.300 (0.18) 0.300 (0.18) 0.300 (0.18)
0.96
Survival is defined as no reoperation to remove or replace sling. *Log rank test.
112
postoperative amblyopia was attributed to ocular comorbidities (congenital cataracts, nystagmus, and glaucoma) because PF measurements were 9 mm OD and 8 mm OS 5 and a half years after surgery, making ptosis an unlikely cause. Visual acuity remained stable or improved between placement of the Supramid sling and last follow-up visit in 42 cases (95%). Only 2 patients had worsening visual acuity postoperatively, both of which had preexisting amblyopia. One case was complicated by multiple granulomas and sling removal. Preoperative visual acuity in this case was 4.7 cyc/cm in the ptotic eye (vs. 9.8 cyc/cm in the uninvolved eye), and vision at last visit was 20/40 in the noninvolved eye and 20/60 in the amblyopic eye. In the other case, there was a significant improvement in PF after placement of a silicone rod to correct recurrence of ptosis, but the patient was subsequently lost to follow up. Correction of torticollis was not documented in this study.
0.96
Ideal timing for surgical intervention in cases of congenital ptosis is after 4 years of age to allow for some growth of the face and eyelid and to lessen the risk of general anesthesia. Many patients, however, require earlier intervention to prevent irreversible vision loss from amblyopia that can be caused by untreated, severe congenital ptosis (see Fig. 3A). A plethora of materials has been studied for use in frontalis sling operations including Supramid, silicone, autologous fascia, Tutoplast (fascia lata allograft), chromic gut, collagen, polypropylene, stainless steel, silk, nylon monofilament, mersilene mesh, GORE-TEX (polytetrafluoroethylene/PTFE), palmaris longis, and others. Some authors previously reported a low success rate in Supramid sling, with early postoperative recurrence; therefore, the use of Supramid has been discouraged. In 1 study, recurrence of ptosis, whether unilateral or bilateral, was noted in all 43 patients included in the study from 1 to 18 months postoperatively. Complications such as granuloma (17%), Supramid exposure (5%) or extrusion (2%), unsightly scarring (5%), eyelid peaking (5%), infection (3%), preseptal cellulitis (2%),
© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
Ophthal Plast Reconstr Surg, Vol. 30, No. 2, 2014
Supramid Sling Longevity in Congenital Ptosis
FIG. 2. Kaplan-Meier plots of the probability of Supramid sling failure defined as reoperation to remove or replace by surgical technique.
FIG. 3. A and B, Pre- and postoperative photographs of a patient demonstrating risk for amblyopia and good functional and cosmetic surgical results, respectively.
corneal cautery burn (2%), and exposure keratitis (2%) were noted in 43% of cases in this study. A Kaplan-Meier analysis
was not performed, but most recurrences (74%) occurred 6 to 18 months postoperatively.7 The authors have used Supramid in children younger than 4 years at the Bascom Palmer Eye Institute due to the secondary site morbidity associated with autogenous fascia lata harvesting in the immature leg, the bulky nature of silicone rods, and the ease of use, excellent cosmetic and functional results (see Fig. 3B), and low rate of infection with Supramid. They found a longer interval of success than has been documented previously, lasting up to 13 years without need for surgical revision. It is important to note, however, that sling effect was time dependent according to the Kaplan-Meier analysis, with 87.8% survival at 1 year and dropping to 54.1% survival at 5 years. In addition, they found variation in longevity with surgical approach, with a higher cumulative proportion failure at 5 years in the double rhomboid group. The reasons for the difference between success rates found in this study for duration of Supramid sling and those of previous studies are not clear, but surgical approach may play a role, as is highlighted in these findings. Limitations of this study included lack of quantitative ptosis measurements in all cases and inconsistent follow up. The decision to use time to additional surgery as the endpoint was validated by this subgroup analysis, which showed that PF and MRD data correlated well with this endpoint (in cases where this data was recorded). An inherent limitation in this method, however, was the possibility that surgery indicated in certain
© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
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Ophthal Plast Reconstr Surg, Vol. 30, No. 2, 2014
R. E. Tanenbaum et al.
cases may have been delayed for unrelated reasons. For example, in the case with longest duration, even though the PF values were 8 in the involved side versus 10 in the uninvolved side 13 years postoperatively, revision surgery with fascia lata was recommended but declined by the patient and family. In this case, the duration of the sling as a measure of initial surgery to last follow up was less accurate in terms of surgical outcome from the surgeon’s perspective. It is interesting to note, however, that this patient did not demonstrate amblyopia, and the eyelid cleared the pupillary axis well even 13 years after the initial surgery. In addition, while 22 cases did not require any additional surgery at the conclusion of the study, based on the Kaplan-Meier curve, it is likely that the 13 of these cases that were lost to follow up had regression of effect over time. Due to the retrospective nature of this study, they are unable to ascertain whether the patients lost to follow up in fact underwent surgical interventions at another facility. In addition, this subgroup analysis by surgical approach may have been biased by the significantly larger percentage of cases performed with the double rhomboid technique (and the lack of statistically significant difference in failure rate). An important endpoint of frontalis suspension in very young children is the prevention (or improvement) of amblyopia. While visual acuity improved or remained stable in 95% of these cases, there were 2 cases with amblyopia development after placement of the Supramid sling. Complications encountered in this study included traumatic breakage of the sling, granuloma formation, and 1 case of infection and recurrent ptosis. Complications have been found with all the sling materials with variable rates.8,9 Soft tissue complications have been seen in up to 20% of cases with various sling materials.8 Trauma is also a common occurrence in this age group, and authors have discussed the association between trauma and Supramid breakage.10 It is likely that the proclivity to break with growth over time and with trauma is one of the drawbacks of the Supramid material. Prior studies have also compared multiple materials for frontalis suspension, and the complication and recurrence rates are fairly high among all other alloplastic materials,9,11 regardless of sling design and suture material used. In 1 study of 102 cases of frontalis suspension, infection and/ or granuloma formation occurred in 10.8% of all frontalis suspensions, and ptosis recurred in 31.4%. In this study, the range of follow-up time was 1 week to 9 years, and cases with
Frontalis Suspension With Supramid Suture: Longevity Results in Very Young Patients With Congenital Ptosis Rebecca E. Tanenbaum, Wei Shi, M.S., Thomas E. Johnson, M.D., and Sara T. Wester, M.D. Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida
Purpose: To evaluate the duration of effect of frontalis suspension using Supramid suture (polyfilament, cable-type 3-0 suture) technique in very young children with congenital ptosis. Methods: The authors performed a retrospective review of 44 patients aged 4 years or less who underwent frontalis suspension using Supramid at the Bascom Palmer Eye Institute. Surgical success was defined as good eyelid height and position. Duration of the sling was defined as the time from initial surgery until additional surgery was performed or the date of last follow up. Kaplan-Meier survival analysis was performed with failure time measured as time from initial surgery until additional surgery was performed. Results: Kaplan-Meier survival analysis showed a success rate of 87.5% at 1 year, 78.2% at 2 years, 74.5% at 3 years, 58.2% at 4 years, and 53.7% at 5 years. Complications were noted in 10 cases (23%) and included damage to the Supramid sling secondary to trauma and granuloma formation. Conclusions: Given the ready availability, ease of placement, and reliable cosmetic and functional results, Supramid suture is an excellent temporizing treatment option in cases of early amblyogenic congenital ptosis in children 2 mm) were demonstrated in 5 of these cases. In these 5 cases, reoperation was not recommended, and the mean increase in PF at last follow up was 3 mm (SD = 2). Those eyes that did require reoperation had a mean PF increase of 1 mm postoperatively. While this 2 mm difference in postoperative PF values was not statistically significant (p = 0.086), the 95% confidence interval (−5 to 0.4 mm) also supports the correlation between quantitative data and need for reoperation. A Kaplan-Meier survival analysis was also performed to analyze the relationship between surgical technique and success of surgery (see Table 2 and Fig. 2). The cumulative probability of Supramid sling failure was 12.4% at 1 year, 24.3% at 2 years, 24.3% at 3 years, 44.7% at 4 years, and 50.2% at 5 years in double rhomboid group and 12.5% at 1 year, 12.5% at 2 years, 30.0% at 3 years, 30.0% at 4 years, and 30.0% at 5 years in pentagonal group (p = 0.96, log rank test). No statistically different failure rate was observed between the 2 surgical methods. Of the total 44 cases reviewed, 5 cases (11%) developed granulomas, all of which were treated with eventual surgical removal of the Supramid suture and 3e of which underwent sling replacement. In these cases, the average time to repeat surgical intervention was 17 months (range 5 months to 3 years), and 4 of the 5 required sling removal at the time of granuloma excision. Three of these cases later had sling replacement with one of each of the following materials: autologous fascia lata, Supramid, and silicone. There
TABLE 1. Kaplan-Meier survival analysis
Time (mo) 3 6 12 24 36 48 60
Cumulative proportion survival at the time
Cumulative proportion failure at the time (1–survival)
SE
0.952 0.904 0.875 0.782 0.745 0.582 0.537
0.048 0.096 0.125 0.218 0.255 0.418 0.463
0.033 0.046 0.052 0.069 0.075 0.093 0.096
Survival is defined as no reoperation to remove or replace sling
© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
111
Ophthal Plast Reconstr Surg, Vol. 30, No. 2, 2014
R. E. Tanenbaum et al.
FIG. 1. Kaplan-Meier plot of the probability of Supramid sling failure defined as reoperation to remove or replace. were no cases of significant corneal exposure problems. Infection was noted in 1 case. Trauma was documented in 5 cases (11%); however, in 2 cases, surgical repair was not initially performed. In those cases, trauma had little to no effect on the eyelid position, but additional surgery was eventually required due to gradual worsening of the ptosis over the following years. In the other 3 cases, there was a clear temporal relationship between the trauma and breakage of the Supramid, and immediate replacement of the Supramid sling was performed. Thirteen cases (30%) were noted to have preexisting amblyopia in the ptotic eye. Two patients without preexisting amblyopia developed worsening vision postoperatively. One case developed amblyopia 1 year after sling placement, which resolved after placement of a fascia lata sling, and vision has been stable since. Another case of
DISCUSSION
TABLE 2. Kaplan-Meier survival analysis Cumulative proportion survival at the time (SE) Time (mo) 3 6 12 24 36 48 60 3 6 12 24 36 48 60
Double rhomboid
Pentagonal
p*
0.941 (0.04) 0.911 (0.05) 0.876 (0.06) 0.757 (0.08) 0.757 (0.08) 0.553 (0.11) 0.498 (0.11) 0.059 (0.04) 0.089 (0.05) 0.124 (0.06) 0.243 (0.08) 0.243 (0.08) 0.447 (0.11) 0.502 (0.11)
1.0 0.875 (0.12) 0.875 (0.12) 0.875 (0.12) 0.700 (0.18) 0.700 (0.18) 0.700 (0.18) 0 0.125 (0.12) 0.125 (0.12) 0.125 (0.12) 0.300 (0.18) 0.300 (0.18) 0.300 (0.18)
0.96
Survival is defined as no reoperation to remove or replace sling. *Log rank test.
112
postoperative amblyopia was attributed to ocular comorbidities (congenital cataracts, nystagmus, and glaucoma) because PF measurements were 9 mm OD and 8 mm OS 5 and a half years after surgery, making ptosis an unlikely cause. Visual acuity remained stable or improved between placement of the Supramid sling and last follow-up visit in 42 cases (95%). Only 2 patients had worsening visual acuity postoperatively, both of which had preexisting amblyopia. One case was complicated by multiple granulomas and sling removal. Preoperative visual acuity in this case was 4.7 cyc/cm in the ptotic eye (vs. 9.8 cyc/cm in the uninvolved eye), and vision at last visit was 20/40 in the noninvolved eye and 20/60 in the amblyopic eye. In the other case, there was a significant improvement in PF after placement of a silicone rod to correct recurrence of ptosis, but the patient was subsequently lost to follow up. Correction of torticollis was not documented in this study.
0.96
Ideal timing for surgical intervention in cases of congenital ptosis is after 4 years of age to allow for some growth of the face and eyelid and to lessen the risk of general anesthesia. Many patients, however, require earlier intervention to prevent irreversible vision loss from amblyopia that can be caused by untreated, severe congenital ptosis (see Fig. 3A). A plethora of materials has been studied for use in frontalis sling operations including Supramid, silicone, autologous fascia, Tutoplast (fascia lata allograft), chromic gut, collagen, polypropylene, stainless steel, silk, nylon monofilament, mersilene mesh, GORE-TEX (polytetrafluoroethylene/PTFE), palmaris longis, and others. Some authors previously reported a low success rate in Supramid sling, with early postoperative recurrence; therefore, the use of Supramid has been discouraged. In 1 study, recurrence of ptosis, whether unilateral or bilateral, was noted in all 43 patients included in the study from 1 to 18 months postoperatively. Complications such as granuloma (17%), Supramid exposure (5%) or extrusion (2%), unsightly scarring (5%), eyelid peaking (5%), infection (3%), preseptal cellulitis (2%),
© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
Ophthal Plast Reconstr Surg, Vol. 30, No. 2, 2014
Supramid Sling Longevity in Congenital Ptosis
FIG. 2. Kaplan-Meier plots of the probability of Supramid sling failure defined as reoperation to remove or replace by surgical technique.
FIG. 3. A and B, Pre- and postoperative photographs of a patient demonstrating risk for amblyopia and good functional and cosmetic surgical results, respectively.
corneal cautery burn (2%), and exposure keratitis (2%) were noted in 43% of cases in this study. A Kaplan-Meier analysis
was not performed, but most recurrences (74%) occurred 6 to 18 months postoperatively.7 The authors have used Supramid in children younger than 4 years at the Bascom Palmer Eye Institute due to the secondary site morbidity associated with autogenous fascia lata harvesting in the immature leg, the bulky nature of silicone rods, and the ease of use, excellent cosmetic and functional results (see Fig. 3B), and low rate of infection with Supramid. They found a longer interval of success than has been documented previously, lasting up to 13 years without need for surgical revision. It is important to note, however, that sling effect was time dependent according to the Kaplan-Meier analysis, with 87.8% survival at 1 year and dropping to 54.1% survival at 5 years. In addition, they found variation in longevity with surgical approach, with a higher cumulative proportion failure at 5 years in the double rhomboid group. The reasons for the difference between success rates found in this study for duration of Supramid sling and those of previous studies are not clear, but surgical approach may play a role, as is highlighted in these findings. Limitations of this study included lack of quantitative ptosis measurements in all cases and inconsistent follow up. The decision to use time to additional surgery as the endpoint was validated by this subgroup analysis, which showed that PF and MRD data correlated well with this endpoint (in cases where this data was recorded). An inherent limitation in this method, however, was the possibility that surgery indicated in certain
© 2014 The American Society of Ophthalmic Plastic and Reconstructive Surgery, Inc.
113
Ophthal Plast Reconstr Surg, Vol. 30, No. 2, 2014
R. E. Tanenbaum et al.
cases may have been delayed for unrelated reasons. For example, in the case with longest duration, even though the PF values were 8 in the involved side versus 10 in the uninvolved side 13 years postoperatively, revision surgery with fascia lata was recommended but declined by the patient and family. In this case, the duration of the sling as a measure of initial surgery to last follow up was less accurate in terms of surgical outcome from the surgeon’s perspective. It is interesting to note, however, that this patient did not demonstrate amblyopia, and the eyelid cleared the pupillary axis well even 13 years after the initial surgery. In addition, while 22 cases did not require any additional surgery at the conclusion of the study, based on the Kaplan-Meier curve, it is likely that the 13 of these cases that were lost to follow up had regression of effect over time. Due to the retrospective nature of this study, they are unable to ascertain whether the patients lost to follow up in fact underwent surgical interventions at another facility. In addition, this subgroup analysis by surgical approach may have been biased by the significantly larger percentage of cases performed with the double rhomboid technique (and the lack of statistically significant difference in failure rate). An important endpoint of frontalis suspension in very young children is the prevention (or improvement) of amblyopia. While visual acuity improved or remained stable in 95% of these cases, there were 2 cases with amblyopia development after placement of the Supramid sling. Complications encountered in this study included traumatic breakage of the sling, granuloma formation, and 1 case of infection and recurrent ptosis. Complications have been found with all the sling materials with variable rates.8,9 Soft tissue complications have been seen in up to 20% of cases with various sling materials.8 Trauma is also a common occurrence in this age group, and authors have discussed the association between trauma and Supramid breakage.10 It is likely that the proclivity to break with growth over time and with trauma is one of the drawbacks of the Supramid material. Prior studies have also compared multiple materials for frontalis suspension, and the complication and recurrence rates are fairly high among all other alloplastic materials,9,11 regardless of sling design and suture material used. In 1 study of 102 cases of frontalis suspension, infection and/ or granuloma formation occurred in 10.8% of all frontalis suspensions, and ptosis recurred in 31.4%. In this study, the range of follow-up time was 1 week to 9 years, and cases with
